FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
9961–9984 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 13, 1999
SAMSUNG RAYPAX LONG TERM ARCHIVE
K992131 · LMB
Samsung Sds Co., Ltd.
Radiology · 82d
Cleared Sep 09, 1999
PHILIPS EASYVISION WORKSTATION:
K990335 · LNH
Philips Medical Systems North...
Radiology · 218d
Cleared Sep 09, 1999
AX WORKSTATION
K992073 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Sep 09, 1999
SAMSUNG RAYPAX FILM DIGITIZER
K992112 · LLZ
Samsung Sds Co., Ltd.
Radiology · 79d
Cleared Sep 09, 1999
RENDER-PLAN 3-D
K992864 · MUJ
Precision Therapy Intl., Inc.
Radiology · 15d
Cleared Sep 08, 1999
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
K992135 · LNH
Ge Medical Systems, Inc.
Radiology · 76d
Cleared Sep 08, 1999
ECHOCARDIOGRAPHY SYSTEM SERIES 95000
K992259 · LLZ
Camtronics, Ltd.
Radiology · 64d
Cleared Sep 08, 1999
MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
K992305 · ITX
Medi-Stim A/S
Radiology · 62d
Cleared Sep 07, 1999
QUANTITATIVE FLOW
K992225 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 67d
Cleared Sep 07, 1999
GENDEX 765DC, MODEL 110-0154
K992610 · EHD
Dentsply Intl.
Radiology · 34d
Cleared Sep 03, 1999
THE NOMOS CHANE II
K991966 · IYE
Nomos Corp.
Radiology · 85d
Cleared Sep 03, 1999
ENDO-ESOPHAGEAL MR COIL
K992193 · MOS
Surgi-Vision, Inc.
Radiology · 66d
Cleared Sep 03, 1999
QCT BONE MINERAL ANALYSIS SOFTWARE
K992246 · KGI
Image Analysis, Inc.
Radiology · 59d
Cleared Sep 03, 1999
LORAD 1-650 (INTERNATIONAL 650)
K992280 · IZH
Lorad Corp.
Radiology · 58d
Cleared Sep 03, 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
K992677 · KGI
Hologic, Inc.
Radiology · 24d
Cleared Sep 03, 1999
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K992753 · MUJ
Varian Assoc., Inc.
Radiology · 18d
Cleared Sep 03, 1999
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
K992896 · EGY
Dental X-Ray Support Systems, Inc.
Radiology · 7d
Cleared Sep 01, 1999
DIGITAL IMAGING SYSTEM (BSR)
K991922 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Sep 01, 1999
VANTAGE EXSPECT II
K992078 · KPS
Adac Laboratories
Radiology · 75d
Cleared Sep 01, 1999
C-QUEST
K992103 · OWB
Wuestec Medical, Inc.
Radiology · 71d
Cleared Sep 01, 1999
SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992761 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Sep 01, 1999
OPTIMAX/ COMPACT 2
K992818 · IXW
Protec GmbH & Co. KG
Radiology · 12d
Cleared Aug 30, 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K991237 · MUJ
Radionics, Inc.
Radiology · 140d
Cleared Aug 30, 1999
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
K992066 · KPR
GE Medical Systems
Radiology · 73d